Can Fasting Decrease the Side Effects of Chemotherapy?

July 18, 2019 updated by: Stacy D'Andre, MD, Sutter Health
This is a prospective randomized crossover trial. Patients will be randomized to the FMD or regular diet during three rounds of chemotherapy. After the third round, patients will cross over to the opposite arm. The primary hypothesis is that there will be fewer cases of Grade 2-4 nausea when patients are in the FMD sequence. The primary objective is to assess differences in toxicities in patients undergoing chemotherapy with a combination of taxol/carboplatin when using a fasting mimicking diet when compared to normal diet before and after treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomization and blinding:

Subjects will be allocated to sequence 1 (normal diet first, FMD second) or sequence 2 (FMD first, normal diet second) using a computer generated randomization scheme. There will be no blinding

Intervention:

Over the course of three rounds of chemotherapy, patients in the FMD will consume a diet that consists of 10 cal/kg/day and includes 50% fat, 40% carbohydrates, and no more than 10% protein. The diet includes nuts, olives, vegetable broth, broccoli/cauliflower, white rice/puffed rice cake, onion, tea/coffee, almond milk. The diet prohibits meat products, dairy, alcohol, sugar, and artificial sweeteners. Patients will be instructed to drink 2 cups of water each morning, take their usual medications and limit exercise to walking.

The table below provides the schedule of fasting during the cycle of chemotherapy

(Time during chemotherapy cycle, Diet)

  • 2 days prior to chemotherapy, Fasting mimicking diet
  • 1 day prior to chemotherapy, Fasting mimicking diet
  • Day of chemotherapy, Full fasting(water only)
  • 1 day after chemotherapy, Fasting mimicking diet
  • 2 days after chemotherapy, Fasting mimicking diet

Prior to each chemotherapy cycle and coincident FMD arm, weight, and laboratory testing will be conducted and patients will be asked to keep track of side effects as per usual care for patients undergoing chemotherapy. Patients will be asked to keep a food log and record the quality of their sleep as part of the study.

There will be no restrictions for use of usual standard medications, including anti-nausea medication. This is generally Zofran oral, q8 hours PRN. Anti-nausea medication usage will be recorded in the study database. Although it is expected to be consistent throughout the diet and control periods for each subject, dosage and frequency will be recorded throughout the study, and it will be noted if anti-nausea medication is effective during the control period for each subject.

Endpoint evaluation:

Severity of AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for toxicity and adverse event reporting. A copy of the CTCAE Version 3.0 can be downloaded from https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf.

AEs not corresponding to the CTCAE term will be assessed according to their impact on the subject's ability to perform daily activities as follows:

Mild (grade 1) - the AE does not interfere in a significant manner with the subject's normal functioning level. It may be an annoyance.

  • Moderate (grade 2) - the AE produces some impairment of functioning, but is not hazardous to health. It is uncomfortable or an embarrassment.
  • Severe (grade 3) - the AE produces significant impairment of functioning or incapacitation and is a definite hazard to the subject's health.
  • Life threatening (grade 4) - Life threatening or disabling.
  • Fatal (grade 5) Causes death of the participant.

Estimated study duration:

Patient participation is approximately 16 weeks.

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • Sutter Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age and older
  • English speaking
  • Patients undergoing chemotherapy with Taxol/carboplatin planned for at least 6 cycles
  • Willing to comply with diet and tests
  • No significant medical problem that would make fasting dangerous (insulin dependent diabetes, history of hypoglycemia)

Exclusion Criteria:

  • Insulin dependent diabetes
  • Pregnancy
  • History of hypoglycemia, or any other medical condition that the treating physician considers not suitable for fasting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FMD (fasting-mimicking diet)
Over the course of three rounds of chemotherapy, patients in the FMD will consume a diet that consists of 10 cal/kg/day and includes 50% fat, 40% carbohydrates, and no more than 10% protein. The diet includes nuts, olives, vegetable broth, broccoli/cauliflower, white rice/puffed rice cake, onion, tea/coffee, almond milk. The diet prohibits meat products, dairy, alcohol, sugar, and artificial sweeteners. Patients will be instructed to drink 2 cups of water each morning, take their usual medications and limit exercise to walking.
Dietary supplement: FMD
fasting mimicking diet
No Intervention: regular diet
Diet not influenced by a fast-mimicking diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea Grade
Time Frame: 16 weeks
Grade 2-4 nausea when patients are in the FMD sequence versus the non-fasting sequence
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FMD Tolerability as measured by adverse events
Time Frame: 16 weeks

Severity of AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for toxicity and adverse event reporting. AEs not corresponding to the CTCAE term will be assessed according to their impact on the subject's ability to perform daily activities as follows:

  • Mild (grade 1) - the AE does not interfere in a significant manner with the subject's normal functioning level. It may be an annoyance.
  • Moderate (grade 2) - the AE produces some impairment of functioning, but is not hazardous to health. It is uncomfortable or an embarrassment.
  • Severe (grade 3) - the AE produces significant impairment of functioning or incapacitation and is a definite hazard to the subject's health.
  • Life threatening (grade 4) - Life threatening or disabling.
  • Fatal (grade 5) - Causes death of the participant.
16 weeks
FMD Tolerability as measured by QOL Questionnaire
Time Frame: 16 weeks
Mean differences in QOL between patients during the FMD versus normal diet sequence will be measured using a repeated measures analysis of variance. QOL questionnaire used will be the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire.
16 weeks
Incidence of neutropenia
Time Frame: 16 weeks
Differences in neutropenia between patients during the FMD versus normal diet sequence
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sutter Health

Investigators

  • Principal Investigator: Stacy D'Andre, MD, Sutter Health
  • Study Director: Carol Parise, PhD, Sutter Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SIMR_Onc18_IIS_D'Andre_Fasting

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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